Gvp Consultant & Auditor

PURPOSE
To be employed as full-time PV auditor for one of seQure clients
ACCOUNTABILITIES
- Planning, preparation, conduct, reporting, and follow up (including CAPA plans) of various types of Pharmacovigilance (PV) audits according to expected quality and timelines
- Follow-up of the GVP Audit responses
- Preparation for GVP inspections
- Participation in the outsourcing of GVP AuditsDelivery of consultancy services (e.g., providing advice to clients and developing Standard Operating Procedures (SOPs), Quality Management System (QMS), risk-based audit strategies, and regulatory compliance issues, and preparation and delivery of training material)Maintaining an up-to-date knowledge of international regulatory requirementsAssist with business development activities
PROFESSIONAL BACKGROUND & EXPERIENCE
- At least 5 years of experience in partner/system audits
- Bachelor's degree in Life Sciences disciplines
- Significant experience in leading and conducting internal and external PV audits for a variety of stakeholders
Contratto di lavoro: Tempo indeterminato
Benefit:
- Cellulare aziendale
- Computer aziendale
- Lavoro da casa
- Orario flessibile
Orario:
- Dal lunedì al venerdì